An interventional study of Combined TDCS active and ICT active and Combined TDCS sham and ICT active in Alcohol Use Disorder, sponsored by Brugmann University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Brugmann University Hospital · Not applicable, Interventional, and Treatment
Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.
Treating Alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. Alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators proposes that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined. tDCS has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ICT is able to modify the automatic approach tendencies towards appetitive cues.
The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT.
Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).
Exclusion Criteria:
Five consecutive days: Twenty minutes of TDCS on the right dorsolateral prefrontal cortex while performing an alcohol-cue inhibitory control training consisting to systematically paired go responses with non-alcohol pictures and no-go responses with alcohol-related pictures.
Behavioral: Combined TDCS active and ICT active
Five consecutive days: Twenty minutes of sham TDCS on the right dorsolateral prefrontal cortex, while performing a no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Behavioral: Combined Sham TDCS and inactive ICT
Five consecutive days: Twenty minutes of active TDCS in association with no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Behavioral: Combined TDCS active and ICT inactive
Five consecutive days: Twenty minutes of Inactive TDCS combined with an non alcohol-cue inhibitory control training consisting to carry out a go/no-go paradigm with no alcohol-related content.
Behavioral: Combined TDCS sham and ICT active
Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
Also known as: Experimental
Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
Also known as: Sham/active
Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
Also known as: Sham/inactive
Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
Also known as: Active/inactive
Reduction of alcohol use in post-treatment at week 2
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time frame: é weeks post-rehab
Reduction of alcohol use in post-treatment at week 4
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time frame: 4 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 2
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time frame: 2 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 4
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time frame: 4 weeks post-rehab
Reduction of alcohol use in post-treatment at week 12
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time frame: 12 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 12
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time frame: 12 weeks post-rehab
Reduction of alcohol use in post-treatment at week 24
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Time frame: 24 weeks post-rehab
Reduction of the relapse rate in post-treatment at week 24
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Time frame: 24 weeks post-rehab
Cue reactivity (attractiveness) at day 22
measures of attractiveness of used and novel alcohol-related pictures: Likert scale ranging from not (score of 0) at all to very much (score of 9)
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity at day 22
measures of attractiveness of used and novel alcohol-related pictures: Likert scale ranging from not (score of 0) at all to very much (score of 9)
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity (valence) at day 22
emotional content (valence) of pictures used in the response inhibition practice and of new pictures. Likert scale ranging from not (score of 0) at all to very much (score of 9)
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity (arousal) at day 22
emotional content (arousal) of pictures used in the response inhibition practice and of new pictures. Likert scale ranging from not (score of 0) at all to very much (score of 9)
Time frame: at post-intervention (day 22 of hospitalization)
Cue reactivity (alcohol verbal fluency) at day 12
Alcohol verbal fluency (from Goldstein et al., 2007; Drug and Alcohol Dependence, 89:97-101 and Hon et al., 2016, Psychopharmacology, 233: 851-861: Participants are instructed to name as many alcohol-related words as possible in 1 min. Responses were audio recorded and independently coded into three categories: neutral, positive and negative valence by two researchers.
Time frame: at baseline (day 12 of hospitalization)
Cue reactivity (alcohol verbal fluency) at day 22
Alcohol verbal fluency (from Goldstein et al., 2007; Drug and Alcohol Dependence, 89:97-101 and Hon et al., 2016, Psychopharmacology, 233: 851-861: Participants are instructed to name as many alcohol-related words as possible in 1 min. Responses were audio recorded and independently coded into three categories: neutral, positive and negative valence by two researchers.
Time frame: at post-intervention (day 22 of hospitalization)
response inhibition at day 12
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Time frame: at baseline (day 10 of hospitalization)
response inhibition at day 22
stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Time frame: at post-intervention (day 22 of hospitalization)
Plan to share: No
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Brugmann University Hospital